Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1510](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1510) → NGJ — Test, Nitrite, Urinary, Non-Quantitative, Over The Counter

# NGJ · Test, Nitrite, Urinary, Non-Quantitative, Over The Counter

_Clinical Chemistry · 21 CFR 862.1510 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGJ

## Overview

- **Product Code:** NGJ
- **Device Name:** Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
- **Regulation:** [21 CFR 862.1510](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1510)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K103037](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGJ/K103037.md) | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | Ind Diagnostic, Inc. | Apr 17, 2012 | SESE |

## Top Applicants

- Ind Diagnostic, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGJ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGJ)

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